Label: NUVALU EPSOM SALT (magnesium sulfate- heptahydrate granule
- NDC Code(s): 72520-002-12
- Packager: J C SALES
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 17, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- DRUG FACTS
- Active Ingredients
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
• Kidney disease
• A magnesium restricted diet
• Abdominal pain, nausea or vomiting
• Notice a sudden change in bowel habits that persists over a period of 2 weeks
• Already used a laxative for a period longer than 1 week
Ask a doctor or pharmacist before use if you are
taking any other prescription drugs. Laxatives may affect how other drugs work
If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Do not exceed more than 2 doses per day
- Drink a full glass (8 ounces) of liquid with each dose
- Dissolve the dose in 8 ounces of water.
Lemon juice may be added to improve the taste.
adults and children 12 years and over 2 to 4 level teaspoons
(10 to 20 grams) dailychildren 6 to under 12 years 1 to 2 level teaspoons
(5 to 10 grams) dailychildren under 6 years consult a doctor - Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
-
INGREDIENTS AND APPEARANCE
NUVALU EPSOM SALT
magnesium sulfate (heptahydrate) granuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72520-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE 100 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72520-002-12 454 g in 1 BAG; Type 0: Not a Combination Product 11/30/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 11/30/2018 Labeler - J C SALES (610969578)